CN103200911B

CN103200911B - For opening the apparatus and method of air flue

Info

Publication number: CN103200911B
Application number: CN201180051973.2A
Authority: CN
Inventors: J·阿雷斯塔德; J·C·古德曼
Original assignee: 5I Sciences Inc
Current assignee: Sommetrics Inc
Priority date: 2010-10-26
Filing date: 2011-10-26
Publication date: 2015-10-21
Anticipated expiration: 2031-10-26
Also published as: JP6166335B2; HK1185786A1; HK1214118A1; CN105232209A; AU2017204232A1; EP2632397B1; CN105232209B; AU2011319865A1; EP2632397A1; JP2013540565A; AU2011319865B2; US11324626B2; AU2011319865C1; JP5931080B2; US20140144450A1; CN103200911A; JP2016052599A; CA2815226A1; JP2017185286A; EP2632397A4

Abstract

A kind of for generation of and/or keep the apparatus and method of straightway upper respiratory tract.Described device is configured at the external position place at the soft tissue place relevant with the front triangle of cervical region roughly corresponding to patient, under the cervical region adjoining patient is assemblied in the chin of patient.Described device can apply negative pressure on the surface of patient's cervical region, thus soft tissue is shifted forward and expands air flue.

Description

For opening the apparatus and method of air flue

Technical field

This application claims the U.S. Provisional Application No.61/406 submitted on October 26th, 2010, the priority of 775, its full content, comprises all charts, accompanying drawing and claim, is incorporated to the present invention all by reference.

Background technology

The discussion done background of the present invention below will only be used for helping reader understanding the present invention, and should not be considered to describe or form prior art of the present invention.

In the medical field, apply outside negative pressure to alleviate to patient or treat to be widely accepted.These " negative pressure " methods need to use some equipment produce at patient desired site place with it and keep different negative pressure (such as, relative to atmospheric pressure) usually.

In one example, " negative pressure wound therapy " (" NPWT " covers (sub-atmospheric pressure) or vacuum sealing technology also referred to as local decompression, low atmospheric pressure) is for promoting acute or chronic wound care, protects from infection and improve the treatment technology of burn-healing.Vacuum source is used for producing low pressure in local wound environment.The dressing comprising drainage tube is coupled to the profile of dark or irregularly shaped wound and utilizes transparent membrane to seal.Described drainage tube is connected to vacuum source, thus open wound is become controlled closure of wound, meanwhile removes surplus fluid from wound bed, to strengthen circulation and to remove refuse.As noted, negative pressure wound therapy has been used for the treatment of acute and chronic trauma, comprises diabetic foot ulcers, decubitus ulcer, wound, burn, traumatic wounds etc.

In another example, outside negative pressure can be applied to patient, for keeping or strengthen the opening of upper respiratory tract (being called nasopharynx, oropharynx, hypopharynx and larynx).There is provided a kind for the treatment of for, described therapeutic kit has such surface, described surface structure becomes encapsulating throat, and (term used herein " throat " refers to that cervical region is anterior, it roughly extends to breastbone top from chin, and extend laterally to the point at external jugular vein rear portion) the perimeter of a part of covering upper respiratory tract, thus compartment (such as, being filled with the hollow space of air molecule) is provided, described compartment is between described surface and throat.Described therapeutic kit is configured to be assemblied at external position place the below of the chin of patient and adjoins its throat, and wherein said external position corresponds to the soft tissue relevant to the front triangle of neck of patient substantially.This therapeutic kit is operably connected to air pump, and described air pump construction becomes the generating portion vacuum at least partially and in this compartment by removing gas molecule in this volume.These method and apparatus may be used for supporting between operation or sleep period such as have sleep-apnea, respiratory tract neoplasms, upper respiratory tract inflammation or traumatic injury the respiratory tract of patient open, with auxiliary intubation, tube drawing, medicine is transported to lung road etc. by the mode of aerosol.

Summary of the invention

The object of this invention is to provide a kind of for assisting the apparatus and method setting up negative pressure region in the outside of patient.

In a first aspect of the present invention, a kind of equipment is provided, on the chin that described equipment is configured to be seated in patient and cervical region, to be substantially positioned at the external position at the soft tissue place be connected with cervical region front triangle of patient, the compartment that restriceted envelope is filled between the inner surface and the skin of user of equipment.When applying the negative pressure for the treatment of level in compartment, the neck surface that the described equipment power be suitable for by vacuum being produced is applied to patient keeps or strengthens the opening of upper respiratory tract, wherein, described equipment is enough firm, to bear the negative pressure of space internal therapy level.

In various embodiments, described equipment comprises flange, and described flange is attached to device end, and when described equipment is located on patient, the surrounding at least partially that described flange is positioned in the periphery of equipment contacts patient skin.Flange in the middle region place is attached to device end by pivot member, and described pivot member is configured to the motion providing flange relative to device end, with the skin contact surface allowing flange to adjust flange, thus adapts to the profile of patient skin.This equipment is operably connected to air pump, to produce the negative pressure of expectation in compartment.Flange can be formed as the integrated component of device end (such as, be molded in a continuous manner during production equipment), or can engage (such as in removable mode, by arranging mating system on flange and equipment, described mating system can by pressing, occlusion, the mode such as to pull on slide fastener and keep together, to form complete equipment).

In certain embodiments, described equipment comprises: neighboring, and described neighboring is configured to the skin contacting user, to encapsulate described compartment; And supporting member, described supporting member is positioned in the subregion of the neighboring of the chin (that is, the central front portion of lower chin) closing on patient, and described supporting member makes equipment be aligned on the chin of patient.

Equipment carrying compartment in by subatmospheric pressure (such as, partial vacuum) loading force, and this loading force is by the edge of equipment, and in certain embodiments by equipment being aligned in the supporting member on the chin of patient, described loading force is applied on user skin.

In order to improve compliance, comfortableness and wear characteristic, flange can under non-stress state flange at least partially on comprise non-rectilinear horizontal section.This non-rectilinear horizontal section be configured to when equipment be located in patient upper and negative pressure is applied in compartment time, improve the distribution of power relative to linear horizontal section.Non-rectilinear horizontal section can be such as recessed or convex relative to patient skin.This is not as restriction.

Alternately, or together with this non-rectilinear horizontal section, equipment can comprise breathable material, described breathable material is that a part for the whole skin contact surface of flange or skin contact surface is inherent intrinsic, or be positioned in the whole skin contact surface of flange or a part for this skin contact surface, wherein, the material structure that can breathe freely becomes when the negative pressure for the treatment of level is applied in compartment, provides by breathable material and enters into the controlled airflow of compartment.Comprise the gathering that breathable material can alleviate heat in compartment and/or moisture.

As mentioned, breathable material can be the inherent structure of flange material.Such as, the instrument (such as, mould) for the formation of flange can provide surface that is coarse or that have microchannel for a part for the skin of the contact wearer of flange.Exemplarily, there is the surface of texture (textured) that the feature of the degree of depth between 0.0005 inch and about 0.020 inch can be comprised.Alternately, breathable material can comprise independent porous material, and described independent porous material can engage (such as, utilizing adhesive tape) in removable mode (and therefore may be disposable).Following describes the example of suitable ventilative material.Be in the various situations of the negative pressure for the treatment of level at equipment under, preferred ventilative material provides the controlled air flow rate being greater than 0.1 liter (LPM) about per minute, in certain embodiments, described controlled air flow rate is between about 0.1LPM with about between 56LPM, and in other embodiments, between about 0.1LPM with about between 10LPM.

In a further alternative, or together with one or two schemes in foregoing, described equipment can comprise low-friction material, described low-friction material has about 0.65 or less coefficient of friction on the whole skin contact surface of flange or a part for skin contact surface, and in certain embodiments, described coefficient of friction is about 0.5 or less, and wherein, low-friction material is configured to the local motion providing flange relative to skin surface.

In a further alternative, or together with one or more scheme in foregoing, described equipment can comprise cohesive material in its edge, and described cohesive material is preferably positioned on the patient contact surfaces of flange.Term used herein " cohesive material " refers to such material, and this material makes to remove such as flange from patient's cervical region needs larger separating force.With regard to the viscosity measurement method of cohesive material, be known in the art multiple standards method of testing (such as, ASTM D3121-94 or ASTM D2979-95).

In a further alternative, or together with one or more scheme in foregoing, described equipment can comprise neighboring, described neighboring is configured to the skin contacting user, to encapsulate compartment, wherein, whole wearer's contact surface at edge or a part for wearer's contact surface comprise the closure (such as, the form of the pipe of fluid filled) of fluid filled." fluid filled " used herein is intended to comprise such material, described material is fluid (comprise and be not limited to liquids and gases), gel, foam, wax, flow particles solid etc., and these materials provide the patient contact surfaces complied with on equipment when negative pressure being applied in compartment.The compliant materials of this fluid filled can in use auxiliary seal equipment and strengthen the comfortableness of described equipment.The closure of fluid filled can divide circumferentially and/or radial direction around multiple districts of the contact surface of equipment, with the area of low pressure preventing inserts from moving to closure.When there is multiple district, these districts can be configured to the independently resistance levels being provided for load.As required, this resistance can be adjusted during manufacture, or control this resistance during use.In addition, some region of equipment, such as, close on the neighboring of chin, can not arrange the closure of fluid filled, to be positioned in alignment area by equipment more firmly.

In certain embodiments, on the chin that described equipment is configured to be located in patient and cervical region, to limit compartment in the external position at the soft tissue place relevant with the front triangle of cervical region being roughly positioned at patient.In these embodiments, described equipment is suitable for when the negative pressure for the treatment of level is applied in compartment, is applied to the surface of patient's cervical region to be drawn onto in compartment on this surface by power vacuum produced, thus keeps epithelium healing open.

In other embodiments, described equipment is configured to be located on the skin of the patient, to limit compartment at the external position place covering wound.

Other element multiple can be set in the apparatus of the present: invention.These elements can comprise in following element one or more:

(i) deflection element, described deflection element is positioned at flange, and described deflection element is configured to reduce the longitudinal stress in flange;

(ii) be positioned at the flange edge of the rounding gone up at least partially of flange;

On flange along the thickness that tangential direction is variable, preferably, the edge of flange has minimum thickness; Such as, the maximum gauge of flange can between about 0.4 inch to about 0.1 inch, and minimum thickness can change between described maximum gauge and minimum thickness for about 0.02 inch or less and thickness of flange.In certain embodiments, maximum gauge is between about 0.312 inch and about 0.25 inch, and minimum thickness is between about 0.01 inch and about 0.005 inch.These sizes do not comprise other structure any or coating that reversibly can be applied to flange;

(iv) air pump, described air pump is connected to equipment via flexible pipe (hose) or hard tube (tube);

(v) air pump, described air pump can be worn by patient and self-powered (that is, do not need to be connected to just can operate for main power source);

(vi) air treatment system, described air treatment system controls temperature, humidity and air-flow in compartment;

(vii) integral sealing component, described integral sealing component is positioned at the outside of flange, and described integral sealing component forms closed air duct around in a part for whole device end or device end;

(viii), when equipment is for keeping epithelium healing open, the subregion not closing on the chin of patient of device end does not comprise low-friction material;

Close on patient chin device end subregion in, supporting member is positioned at inside the device end that is configured to coordinate with the chin of patient; With

(x) integral sealing component, described integral sealing component is positioned at below the whole skin contact surface of flange or a part for skin contact surface, wherein, contact surface between containment member and flange provides territory, low friction zone, and described low friction zone domain construction becomes to provide flange relative to the local motion of skin surface.In these embodiments, lubricating fluid can be placed between containment member and flange, to alleviate the friction at contact surface place.

Those technical staff in this area will be appreciated that the disclosure based on concept easily can realize other structure of some objects of the present invention, the basis of method and system as being designed for.Therefore, importantly, as long as such equivalent constructions does not deviate from the spirit and scope of the present invention, then claim should be considered as comprising these equivalent constructions.

Accompanying drawing explanation

Fig. 1 and Fig. 2 depicts the sectional view passing equipment at the level height place of patient contacting area.As shown in the figure, flange can be configured to integral with apparatus body (Fig. 1) or the parts (Fig. 2) as reversible attachment to the junction point of equipment;

Fig. 3 and Fig. 4 schematically depict the power when the patient contacting area place being carried in equipment in use procedure;

Fig. 5 schematically depict substituting flange shape (rounded edges) in use on the impact of power at patient contacting area place being carried in equipment;

Fig. 6 schematically depict substituting flange shape (cantilevered lip) in use on the impact of power at patient contacting area place being carried in equipment;

Fig. 7 depicts the sectional view of equipment, shows the lower flange with concave contour;

Fig. 8 depicts multiple projections, shows the impact of circumferential rigidity on device shaped;

Fig. 9 depicts multiple embodiments of the circumferential rigidity for reducing equipment;

Figure 10 depicts use ventilating layer, in use to control the heat that can gather in equipment and aqueous vapor level;

Figure 11 A depicts a kind of embodiment, and in the described embodiment, ventilating layer is formed by the lamination heap be made up of multiple material;

Figure 11 B depicts a kind of embodiment, and in the described embodiment, the surface with microchannel is used as the parts of ventilating layer;

Figure 12 and Figure 13 depicts a kind of system in schematic form, and described system is for managing the environmental quality in equipment of the present invention;

Figure 14 depicts alternate embodiment, and described alternate embodiment is for managing the environmental quality in equipment of the present invention;

Figure 15 depicts equipment of the present invention, and described equipment has the different region of frictional behavior on the patient contacting area of equipment;

Figure 16 depicts a kind of equipment of the present invention, and described equipment is configured to the shearing force providing improvement during head movement;

Figure 17 depicts such embodiment, and in the described embodiment, the patient contacting area of equipment of the present invention is modified as control frictional behavior;

Figure 18 and Figure 19 depicts and uses clip that equipment of the present invention is fixed to user;

Figure 20 and Figure 21 depicts the embodiment of equipment of the present invention, and described embodiment comprises cup-shaped alignment member, with suitably place apparatus auxiliary on the chin by equipment being aligned in wearer.

Detailed description of the invention

Outside negative pressure treatment apparatus

Miniaturized design for negative pressure treatment apparatus is so a kind of structure, described structure is configured to the compartment providing space to fill between the inner surface and the skin of user of apparatus, wherein, described structure is enough rigidity, to bear the expectation parital vacuum produced in space, and provide edge, neighboring, edge, described neighboring is sealed to the skin of user, to encapsulate compartment.About 7.62cm to about 60.96cm H will be in ₂vacuum within the scope of O is applied to about 32.90cm ²to about 210.58cm ²skin surface area, to apply the vacuum for the treatment of level expected.These external treatment apparatus need interface usually, described interface by encapsulated spatial joins to external vacuum source and power supply, with the curative effect realizing expecting in whole treatment cycle.

A. therapeutic kit

Therapeutic kit of the present invention comprises: structural elements, and described structural elements provides the compartment between the inner surface and throat crust of apparatus, and wherein, described structure is enough rigidity, to bear the partial vacuum needed for producing in space; With edge, neighboring, edge, described neighboring is sealed to the skin of user, with envelope space.Can by being combined to form of any material or material, molded or manufacture container.The non-limiting example being suitable for this material constructing described therapeutic kit comprises plastics, metal, natural fabric, synthetic textiles etc.Described apparatus can also be formed by the material structure with the such as silicones of elastic memory, rubber or urethanes.

To unique restriction of the material (multiple material) manufacturing therapeutic kit be, described apparatus must be nontoxic (or " bio-compatible ", because it contacts with skin), and must be enough rigidity, to maintain space while the partial vacuum load expected in carrying.Durometer value (durometer) or hardness are the units representing material repels indenture.Provide the durometer value of normal part material in the following table:

Material	Durometer value	Shore scale
			Bicycle gel vehicle seat	15-30	OO
Chewing gum	20	OO
			Sorbothane	40	OO
Rubber band	25	A
			Door weather strip	55	A
Automobile tire tyre surface	70	A
			Soft slide plate wheel	75	A
Hydraulic pressure O type circle	70-90	A
			Hard slide plate wheel	98	A
Vulcanie	100	A
			Solid truck tyre	50	D
Safety helmet	75	D

The periphery contact surface of therapeutic kit can be made up of material that is softer, that more have compliance compared with the structural region of apparatus.Durometer value is decreased to (Shore OO between 15 and 30; Be roughly the hardness of chewing gum or rubber band) contact surface can be allowed to fill the profile of skin better.Be known in the art the semi-solid preparation or uncured rubber with approximate gel-like consistency.Therein and itself not there is the material of enough architectural features (such as, p7616-160A/B RTV-2 rubber, Wacker Chemie) when, thin bladder (polyurethane of such as 1mm) such as can be used to carry out encapsulating material.These materials can join the structural region of apparatus in two parts mold treatment.

The whole contact surface of therapeutic kit or a part for contact surface can provide the material be clamminess, described in the material that is clamminess improve bonding between apparatus and wearer's skin.This material be clamminess can be formed as the integral part of apparatus, or can be formed as the material that can be changed by user.Some pressure sensitive adhesive (" PSA ' s ") can present various ways, such as acrylic resin, silicones, rubber and watery viscose binder.The standard method of classification adhesive strength peels off test by 90 degree of samples of PSTC or ASTM.Contact adhesive in every scale inch 0.2 to 2.0 pound of scope is desirable.Excessive intensity has a negative impact to removing apparatus.Preferred material comprises RTV silicones, such as (Wacker Silicones), comprises p7671A/B or 2120A/B.These materials have biocompatibility, by gamma sterilization, and control cohesiveness by changing the amount of adding the catalyst of vulcanization reaction to.RTV-2 elastomer is bi-component product, and described bi-component product is solidified into solid elastomers, gel or flexible block foam at ambient temperature when mixing.RTV-2 is solidified by mixing two kinds of composition A and B.By incomplete solidification, silastic material keeps soft and has viscosity.

Because power is applied to the skin (owing to being pressed against on skin, so user can power described in perception) of user by the contact surface of apparatus due to the treatment power that produces of vacuum, may cause using apparatus so lack comfort.In some cases, the blood capillary in skin below edge or lip, small artery and venule also may be collapsed when long-time use.Therefore, the invention describes some technology that can strengthen the comfort level relevant with using negative external pressure (cNEP) therapy.Although below describe the device be absorbed in for keeping or strengthen airway open, those of skill in the art will understand, and these concepts are applicable to negative pressure device usually.

A. the joint of flange and dome and shape

Equipment is preferably made up of the soft and material with compliance, although one regionally has enough rigidity, to bear the vacuum for the treatment of level, and can not collapse simultaneously.Due to the multiformity of anatomical shape, therefore plurality of devices size and dimension is required.Feel that in order to make user equipment is held firmly in place, equipment de-sign one-tenth tightly aligns with mandibular bone by arranging alignment (registration) element (dividing plate) be shelved on below chin.As shown in Figure 20 (dotted line region), " cup " shape region receiving chin is formed by the edge of equipment and described dividing plate.As shown in figure 21, the chin pocket formed thus can provide visual signature, and described feature is auxiliary guarantees clip to be suitably placed on chin.In addition, by being applied in the structure of the relative stiffness of chin by the part produced in the load at equipment/patient contacting portion place, the leverage (leverage) of improvement can be obtained on the pharyngeal soft tissue covering movement.

Advantageously, near the lug area of ear and cervical region be configured with compliance and with the anatomical structure self-aligned of wearer.Fig. 1 depicts the cross section through dome part and flange.In the drawing, flange is depicted as with device end integral.Junction surface shows very thin section at an A place, the mid point of the contact surface that described section roughly contacts with skin at flange.This thin section is very weak and allow the free pivotable of flange.This is favourable, because reduce the region of the high contact pressure caused because of flange and cervical region misalignment.Fig. 2 shows the alternate embodiment of design, and in described alternate embodiment, flange is reversibly attached to device end by click joint.

The flange of suitable aligning still can apply high contact pressure point, unless it is designed to solve the behavior that (address) is positioned at the tissue below it.The important key property of tissue is its compression stiffness.Described compression stiffness changes along with the tissue thickness be captured between equipment and the stone structure of such as bone or cartilage.The individuality with extra fat tissue will have less rigidity or softer system.In the process of the periphery of the equipment flanges that moves around, rigidity is organized to change according to the roughness of skin and fabric.Therefore, an anatomic region may be different with the relative compression stiffness of another anatomic region, and present individual user difference.Comfort is imperceptible pain.High contact pressure within a certain period of time can cause pain.Actual uncomfortable region can be very little; It can be edge and even be a point.

Fig. 3 shows the zoomed-in view of the equipment flanges being loaded into tissue with typical way.The flange design do not loaded becomes to have nonlinear end profile, and described end profile is at equipment distal flex.According to the loading shape of load, material behavior, width and tissue characteristic determination flange.The shape (with reference to smooth tissue) loading flange preferably with regard to flange central authorities 80% with regard to be smooth substantially, and 10% condition at each edge to be all bent upwards.When the load applying of the dome part from equipment is to flange, the far-end of flange bends backward and straightens.In order to object clearly, the sectional view of flange will illustrate straight contact surface.In fact, straightly the dissection curve following human body is meaned.Structure below flange also keeps being skin, muscle/fatty tissue and bone respectively, and this structure has the characteristic of nonlinear spring rates.Therefore homogeneous compaction organizational structure will produce consistent contact pressure.But due to the structure cohesiveness of tissue, therefore flange edge condition presents and is applied organizationally by higher stress.This is represented as an A.Fig. 4 shows region C.This is the potential energy relevant with the natural curve compress tissue according to skin surface.The displacement tissue of natural curve changes into a stretching term at B place (tensile term).

Square bearing load under the flange, and tissue will feel increase.Apply in skin or on total stress be the resultant of compression stress and side direction tensile stress.Fig. 5 shows flange edge design, and described flange edge design comprises rounded edges.This rounding reduces peak stress in two ways; First, reduce the potential energy region shown in Fig. 4, and less at an A place contact stress item.Desirable solution selects minimum radius, and described minimum radius will produce flange edge total stress condition, the nominal stress in the middle section of described edge total stress Condition Matching flange.The variable considered during design ideal radius comprises the anatomical shape and thickness such as organized.According to direct measurement, flange edge radius is advantageously between 0.02 inch to 0.25 inch.In addition, radius can preferably with the skin contact surface of flange and tangent with the central point of flange edge at a distance of 70% place of radius value.Although this design is simple radius, other embodiment can provide benefit.They can present the form on inclined-plane or any mathematic(al) representation, and described mathematic(al) representation describes the curve from ledge surface to edge.

Fig. 6 shows the design of the rounding curve of the expectation of setting up in the thin lip by bending silicone material etc. in a cantilever fashion.This feature can with equipment and/or flange is integral or not with equipment and/or flange integral.The favourable part of this design is, the thin lip under non-stress state is at equipment distal flex.This keeps the effective sealing preventing escape of air inherently.

B. the method for the negative effect of longitudinally (circumference) rigidity is reduced

The lower flange crossing cervical region front of equipment is bending, to mate the shape of cervical region.This bending prevention flange and cervical region autoregistration.When flange attempts pivotable, the top of flange and the circumferential lengths of bottom margin will be lengthened out respectively and shorten.Because material is relatively hard, therefore it only stops aligning.Fig. 7 is the sectional view of equipment, shows rotating hinge point and the lower flange with recessed profile.Fig. 8 A and Fig. 8 B is two projections of flange.It illustrates stretching, extension and the protuberance (bunching) of flange edge material.Fig. 9 A shows by increasing with the form of local slot the method that discontinuity reduces longitudinally (circumference) rigidity.Slit is oriented orthogonal to flange length, and therefore can not affect the favourable load diatibution feature of flange.Fig. 9 B shows alternate embodiment.

C. the air in conditioning equipment

Sleep apnea continues to connect subject chronic disease between sleep period a kind of needs.Equipment is by the region of encapsulating cervical region, and this may usually make user feel hot and moist.These uncomfortable situations may be ordered about user and be attempted arranging apparatus again, thus cause leakage air, and extremely easy from sleep wake up with a start.Promote that air flows through equipment by contributing to alleviating the negative effect of humidity and temperature, especially in the application of long-time wearable device.

Figure 10 is the sketch of ventilating layer, and described ventilating layer promotes flow of external air by sealing flange and enters into equipment cavity.Ventilating layer is made up of half annular distance (semi-porous) material with biocompatibility, and described semi-ring porous wood material has enough structures and collapses with opposing, keeps air duct thus.This material provide not only the air line leading to equipment, but also provides air contact for skin, makes gas and moisture can free exchange.This can be used in the skin injury relaxed because heat and dampness cause or worsen.0.1 standard cubic foot (LPM) about per minute is greater than, in certain embodiments between about 0.1 with about between 56LPM, and in other embodiments, between about 0.1 with about between 10LPM by the preferred air mass flow of equipment.Typical material can be foam, woven cloth and non-woven deposited stratification (layup).When equipment flanges be specifically designed to minimize peak value tissue contact pressure, ventilation unit must be thin, can not offset the effect of flange.Air mass flow can be changed according to the flow behavior of selected material.Such as, reducing air path length 1/2 will cause flow to double; Reducing material thickness 1/2 will make flow reduce by half.

Because this ventilating layer (lining) and skin close contact, therefore life of product may be restricted to only several days.This will benefit from simple device, for removing and again applying new lining.For this application, pressure sensitive is desirable.By pulling special tab, lining being peeled off, old lining can be removed from equipment simply.By peeling off backing paper, lining to be positioned on equipment and to apply slight contact pressure to apply new lining.Lining can be constructed by the porous material not being monolayer and form.It can be made up of the parts of laminated multi-layer.Such as, see the decomposition view of Figure 11 A.Equipment is made up of silicone rubber, and therefore may need special binding agent.Typical lamination heap will be formed by with lower part: ventilating layer, acryloid cement, polyurethane film, silicon resin adhesive are formed and final equipment.Acryloid cement should be higher than silicon resin adhesive intensity, to guarantee to remove lining neatly from equipment.And the viscosity of silicon resin adhesive goods and polyurethane film must be greater than the viscosity with the silicone material of equipment.

The extra play that low-friction material is made also can be applied to the ventilating layer of lining in vital region, to relax the friction (chaffing) to skin.Will be discussed in detail below preferred position.Below the example of possible binding agent: 1. acrylic acid; 2. silicones; 3. watery glue.

Figure 11 B depicts another embodiment that equipment and sealing area are ventilated.In this case, the contact skin side of equipment flanges will comprise cancellate microchannel, and described microchannel is provided for the pipeline of air-flow.The aspect ratio of passage is by deeply to being enough to prevent neck tissue from moving to bottom and block airflow.The ratio of channel depth and width can change between 1 and 4.Channel width can change between 0.0005 to 0.020.Flange surface areas for access portal can in the scope of 5% to 20%.Grid can be constructed in injection molding tooling.Multiple technologies can be applied, such as micro Process, chemical light etching or laser-induced thermal etching.And, the auxiliary manufacture treatment step of such as laser-induced thermal etching directly can be used in equipment flanges.

Withdrawing air is not enough by flange for some user simply.Air in conditioning equipment can comprise heating, cooling and controlled humidity.Figure 12 shows by the vacuum of dual circuit pipeline and one and the system that forms of air-conditioning unit.The air of adjustment that described system will be metered in equipment, and utilize vacuum pump air-out.Connection tube can be two pipes in sheath, described two tube side-by-sides or integrally molded with one heart.Figure 13 shows typical control program, and described control program is made up of microcontroller, pump, intake valve, heater, cooler and pressure transducer, temperature sensor and humidity sensor.Microcontroller will compare sensor input value 4 and desired value, and correspondingly adjust pump discharge, intake valve, heater and cooler.Such as, in order to reduce humidity and/or temperature, will intake valve be opened, thus increase the air mass flow by equipment.When first time goes to bed, some people likes warm air.This can utilize electrical heating or be realized by the intrinsic heat of pump and motor generation by utilizing.Other people may like the extra cooling effect making the temperature levels in equipment lower than room temperature.System will utilize solid-state thermoelectricity (peltier effect) to cool.In addition, can comprise the maximum air-circulation features of short-term, when apnea being detected at every turn, described air-circulation features will circulate.Other air system closed circulated when can be included in there is removable desiccant for the device reducing humidity.

Two-pipe system is the simplest air flow system, and described two-pipe system has supply opening and floss hole in the middle section of equipment.But, require that any equipment de-sign of higher air exchange rate all needs higher pump discharge.Supply opening and floss hole are positioned near the end of equipment by more effective design.Therefore, the forced draft skin surface that will be advanced through roughly 8 square inches before emptying equipment.This will maximize the effect of management humidity and temperature.

Figure 14 illustrate in detail and supply (adjustment) air is transported to method in circular passage, advances in described circular passage on the whole periphery of equipment.Supply pipe connector and annular compartment are via the one core in equipment or be connected by external device (ED).The advantage of this design is, side is driven across the air of adjustment under the flange.Regulate surface area 30% to 50% because lug area adds whole skin, thus improve effectiveness.Circular passage and external isolation is supplied by air by lip seal.

The multiple denser venting materials of such as foam is suitable for strengthening comfort level ideally, but too much air may be made to pass through.But, these venting materials can be used by utilizing auxiliary device to control air mass flow.Auxiliary device can be throttle orifice or control valve.As depicted in Figure 14, equipment de-sign will have circular passage that is complete or part.The air of admission passage is controlled by one or more throttle orifice or similar flow control apparatus.

C. the positional stability of equipment rubs with reducing

When applying treatment vacuum, by vacuum power and the friction between skin and silastic material, equipment is firmly held in suitable position.Equipment is preferably designed so that the contour shape of coupling mandibular bone, and this causes equipment to follow nature head movement.Although which establishes good positional stability, it is disadvantageous for cervical region.When head/equipment moving exceedes slackness (flaccidity) of skin, will slide.This causes user to be scratched and causes discomfort.

Describe two kinds in the disclosure for avoiding the method for this kind of friction (chaffing): first method is the friction of the material used in reducing neck area, second method is by separately mandibular bone and neck flange eliminate cervical region slip.Figure 15 defines different regions on flange, makes it possible to use high frictional behavior and low frictional behavior to come positional stability and the user comfort level of optimization equipment.Although this is single method, there is the embodiment that many kinds can produce similar results.There is the multiple material presenting broad range frictional behavior.These materials are including, but not limited to textile fabric, non-woven fabrics, plastic sheeting and binding agent.Material is limitedly listed and it is to the frictional behavior coefficient of human body skin in following table.

Material	Coefficient of friction
		Break-resistance nylon	0.71
Silk	0.70
		The spandex of loose weave	0.69
The spandex of close weave	0.66
		Black spandex	0.56
Wrinkling cotton	0.69
		Cotton	0.77
The chiffon of loose weave	0.56
		The chiffon of close weave	0.53
Lightweight cotton	0.68
		Cotton (1)	0.73
Cotton (2)	0.62
		Satin	0.41
Mei Di side (Medifoam) #30	0.81
		Neoprene soft formation face	0.61
Neoprene hard formation face	0.55
		Lamination sample (1)	0.74
Lamination sample (2)	0.67

Such as, the U.S. enlightening virtue #30 be placed in mandibular bone region provides good positional stability with the satin be placed in neck area, and does not cause discomfort of neck area simultaneously.In addition, aid in treatment conditioning equipment flange self can be passed through, to change coefficient of friction.

Figure 16 shows equipment building method, and described equipment building method minimizes flange at head to the side force be applied to when rotating to side on cervical region.Existing equipment design comprises simple dome part, effectively to react on vacuum power.Because material is in plane substantially, thus simple dome part between upper flange and lower flange laterally shear direction produce firm relation.In order to alleviate this phenomenon, need to carry out softening section modulus characteristic by adding the part that vertically caves in dome part.By keeping the arc of dome part, to carry vacuum-load.

Figure 17 A and Figure 17 B shows some images of equipment, and described equipment has the thin film or film that are attached integratedly.This film is between device support flange and user skin, and thickness is between 0.004 inch to 0.032 inch.Along with head movement, equipment flanges will be moved, and meanwhile, flexible film keeps fixing relative to skin.This forces between equipment flanges and film and relative motion occurs, thus eliminates the scuff mark on user cervical region.The coefficient of friction reducing between flange and film by using any traditional liquid, gel or dry lubricant.

The method of Figure 18 positioning equipment securely while showing and fabric ventilating layer being set between equipment flanges and user's skin.Outer fabric is soft open-weave net, and the open-weave net of described softness promotes that air is in cervical region cocycle.It utilize at rear portion buckle or pull stap fastening.Inner fabric is ventilating layer, and can be thin cotton or analog.Internal layer is sewn to outer fabric in the periphery of equipment.Extra material is filled in equipment, to provide the space for organizing leading to equipment under vacuum.Figure 19 depicts embodiment with sectional view.

B. generating portion vacuum-air pump

When using at this, such device that term " air pump " refers to, described device removes gas molecule from closed chamber, with forming section vacuum.

Vacuum can be produced in many ways in the compartment formed by described apparatus and user skin.A kind of simple method uses elastic shape memory material to manufacture described therapeutic kit, and described elastic shape memory material can be compressed as bulb, and the throat of coupling user, is then released.In this case, when described apparatus is matched throat and discharges described apparatus, described apparatus returns to its original shape, thus in space generating portion vacuum.

The preferred dynamic design of pump module adopts positive displacement pump, is most preferably to adopt by linear motor or the membrane pump having brush or the driving of brushless direct-current turning motor.In the particularly preferred example using linear motor, linear motor is operatively connected with control circuit, and described control circuit is configured to the single discrete stroke of driving pump and multiple stroke.In the particularly preferred example using dc motor, be connected with controller to electric motor operated, described controller is configured to single discrete rotation and the multipurpose rotary of drive motor.The example of these and other suitable air pump is hereafter described.

As being incorporated into as described in the WO2009/112866 in the present invention by reference at this at its full content, another preferred dynamic design employing dish pump (disc pump) of pump module.In this dish pump, end wall and sidewall define main chamber.Although can also use oval and other shape, described chamber is preferably circular.Chamber is provided with node air inlet and the air vent of valve is housed.Actuator comprises the piezoceramic disk being attached to dish.When applying suitable electric drive, actuator vibrates along the direction of the plane being basically perpendicular to chamber, thus the interior radial pressure that produces of fluid in the chamber fluctuates.The lowest resonance frequency of the radial fluid pressure oscillation in main chamber is preferably more than 500Hz, and the frequency of oscillating movement can be in main chamber radial pressure fluctuation lowest resonance frequency 20% within.

A. air pump type

When using at this, term " positive displacement pump " refers to a kind of such mechanism, and it makes chamber expansion repeatedly, allows gas molecule to flow in chamber from described compartment, closes chamber and be discharged in air by gas molecule.The preferred candidate of " positive displacement " type vacuum pump is: vane pump and membrane pump.

Vane pump uses the rotary components in pumping compartment to make gas motion by pump, and described rotary components makes gas move to outlet from entrance.When the rotor is turning, housing is just touched in the end of blade, thus creates the sealing from import to outlet.During half period, because the volume between blade reduces, gas is pressurized, and during other half period, by air inlet suction gas.Vane pump produces pressure pulse, and described pressure pulse equals the speed of the number of blade and the blade rotation comprised in pump.Because blade type pump does not keep vacuum in whole blowback road, so described system comprises check-valves by between pump and the partial vacuum compartment of encapsulating, to prevent vacuum leak.This pump has low-down detent torque, and will be very suitable for using together with dc motor.Compared with other pump, because produced frequency noise is higher, so can work together with noise elimination technique hereinafter described well.

For small-sized to for medium-sized applications, as the replacement scheme of vane pump, membrane pump is widely used.Membrane pump only needs to carry out considerably less maintenance, and very quiet.The function of membrane pump is realized by the barrier film mechanically moving air-out.A pair check valve is provided, to guide air movement, thus produces vacuum.These valves also will provide canned pump loop to make it the necessary function with the partial vacuum compartments encapsulated.

In this pump classification, there is several method realizing diaphragm movement.Barrier film can be directly connected to armature by linear pump, and along rectilinear direction vibration armature.In such pump, Motor Control can be very simple.Drive the linear motor of linear pump can slowly moving regulator, from the angle producing noise and vibration, this may be favourable.Rotary membrane pump utilizes rotary part that barrier film is struck axial mechanical transducer.They have lower detent torque and can be connected with dc motor.These pump low prices.

In another kind of replacement scheme, air pump can be dynamical type pump (such as, regenerative pump).In regenerative pump, vane rotary, thus produce centrifugal force, described centrifugal force makes air molecule move to its end from root of blade.Leave blade end, air flows around case outlines and turns back to the root of next blade downwards, repeats flow pattern at the root of this next blade.This move provides (quasi-staging) effect of similar segmentation, to increase pressure reduction ability.The speed of rotary blade determines the degree of pressure change.This pump is suitable for outside (such as, the desktop) vacuum source being different from the vacuum source be supported on user described here most.

Particularly preferred pump is so a kind of membrane pump, and the single-stroke discharge capacity of described membrane pump is 0.001 and 0.01in ³between, and be the most preferably in 0.003 and 0.005in ³scope in.Discharge capacity is about 0.004in ³pump will produce 12in when using rotating brushless dc motor with the revolution of 3000rpm or using linear DC motor to drive at 60 hz ³the maximum speed of exhaust of/min.This can will enclose 0.5 to 2in within the time of 2.5 seconds to 60 seconds ³between the apparatus of volume be emptied completely.Certainly, the vacuum producing treatment level does not need the compartment finding time to be closed by described apparatus completely.Such as, 8in is being provided with ³in the apparatus of compartment, remove about 1.6in ³suitable operating pressure can be provided.Therefore, 1 to 25in ³the full speed pumping mode of/min can produce the vacuum level be used for the treatment of rapidly in described apparatus.

After finding time at first, only just drive air pump when needed, more than threshold value partial vacuum being remained on expectation.Suppose escape of air to the leak rate in enclosed compartment between 0.005 to 0.5in ³between/min, then can drive membrane pump, pulse single stroke once with several seconds to a few minutes.Thisly to find time/quiet two-mode method has many advantages, comprise very quiet, vibration is comparatively light and battery consumption is lower.Such as, preferred pump can with between 0.005 to 0.5in ³speed between/min is (most preferably 0.01 and 0.1in ³the speed of/min) condition under run with stillness mode, this can remove 2.4 to 240in in time of 8 hours at night ³air.Assuming that pump rate is one second 5 stroke and supposes that pumpage is 0.004in ³/ stroke, then this pump can operation per minute 0.25 to 25 second, but still provides the performance of expectation.

B. motor types

This apparatus needs the effective use of slow speed operation and fast operating, low noise generation level and battery.In dc motor, when motor is applied in rated voltage, described motor operates at full speed.In order to control rate, the time that one section, motor is shorter must be closed.Usually, the voltage of this motor is provided with square wave.This side's wave frequency is (optimally in the scope of 2,000 to 18,000Hz) usually quickly, and the electricity that receives of motor and the percentage of time of square wave "ON" to "Off" proportional.This technology is called as pulse width modulation (PWM).Short pulse due to full voltage produces very strong magnetic field (its part producing high degree of controlled rotates), and therefore pulse width modulation adapts to the slower motor speed needed for " stillness mode ".Run in slowly velocity interval and may need to add encoder, to be provided for the feedback of accurate control rate to controller.

C. vacuum control

Vacuum control can be provided by machinery and/or electronic control mechanism.The simple mechanical mechanism controlling the vacuum in apparatus compartment is to provide the micro vacuum relief valve be press-fitted in the interface of apparatus.Relief valve is selected to introduces air when exceeding the vacuum level of preliminary election.Then, with constant speed drive air pump, wherein carry out control section vacuum when vacuum exceedes the level of expectation by opening vacuum release valve, and carry out control section vacuum when the level of vacuum lower than this expectation by closed vacuum release valve.Eliminating by inserting suitable vacuum relief valve the less desirable superpressure state surmounting preset range, being chosen as preferably operating vacuum level between about 7.6cm water in the scope of the water of about 61cm.In this embodiment, do not need monitoring inner vacuum or control to drive gas pump motor.But the present embodiment tends to produce unnecessary noise, and so that less desirable speed battery electric power may be used.Preferred electronic/mechanical vacuum control mechanism can comprise: microcontroller, and described microcontroller is connected to vacuum or pressure transducer; Electromotor control circuit, and battery module.

Many optional features can be adopted to come performance and the control of modifying device.Such as, because the known volume encapsulated by apparatus and user skin of cardinal principle, so the time reached needed for partial vacuum can be calculated.Vacuum or pressure transducer detect that vacuum level declines, and this needs primer pump and motor.If determine not realize partial vacuum in one section of reasonable time, then vacuum source of can stopping using, and optionally provide alarm state.Suitable alarm can comprise vision (such as, light), audition (such as, the tinkle of bells) and/or sense of touch (such as, vibrating) instruction.

At treatments period at least partially, partial vacuum can be circulated to lower level, to change the power load at the contact surface place contacted with user skin.Optionally, controller circuitry is programmable, to allow user or healthcare givers to revise various parameter, and such as vacuum level, alarm, sensor type etc., and some optional feature that such as noise compensates.

A. one or more vacuum/pressurized sensor

As above discuss, the vacuum transducer of the pressure reduction determined between chamber portion vacuum and ambient atmosphere pressure can be connected to controller, and described vacuum transducer be used for partial vacuum is remained on aspiration level.Suitable micromachined silicon sensor in the encapsulation that printed circuit board (PCB) known in the art can mount.These sensors can comprise temperature-compensating or calibration circuit, or this circuit can optionally provide as independent electronic unit.Vacuum pressure transducer provides the voltage proportional with the pressure changed (such as, increasing vacuum) to export usually, and absolute pressure transducer provides the voltage proportional with the pressure increased (such as, reducing vacuum) to export usually.

D. data input and output

Microcontroller is preferably operably connected to data input device, such as keyboard or touch screen, with the partial vacuum level allowing user or healthcare givers to arrange expectation.In a simple form, can repeat to press single button, wherein, by microprocessor the number of times pressed the button counted and converted thereof into vacuum setting by microcontroller.In more complicated device, display can provide the numeral of current setting to read, and up/down arrow key is used for increasing/reduce setting.Finally, keyboard can be adopted to input the setting of expectation simply.In all cases, data input device can communicate with control module in wired or wireless manner.When nursing staff sets vacuum level, advantageously make data input device or separate with control module or can remove from control module, making to modify in not controlled mode.

Equipment of the present invention can be configured to record and/or respond various property sensor.Term used herein " property sensor " refers to some characteristic and the sensor producing the electronic result of corresponding described characteristic of detecting user.As mentioned above, in this area, become known for the many sensors detecting breathing cycle, apnea and snoring events, such as, critesistor, acoustic sensor, oximeter (oximiter), vibrating sensor etc.Its full content of U.S. Patent bulletin 2006/0009697(is incorporated to the present invention by reference) disclose a kind of low section (low-profile) disposable system of unitary type, described systematic survey comprises the various vital signs of blood pressure, and without the need to using rubber pocket cuff.This information and out of Memory can by wired or Wireless connections easily from patient transmission to central monitor.Such as, utilize described system, healthcare givers or can monitor the blood pressure of patient and other vital sign during the daily routines of patient continuously as patient admits.Described system can also use same optical system for Measure blood pressure to characterize Heart Rate and blood oxygen saturation.These information wirelessly can be transmitted together with blood pressure information, and for diagnosing the heart of patient further.

In the use procedure of therapeutic kit described here, these sensors can be worn by user, and the information of from then on collecting is transferred to nursing staff or is chosen as other personnel received about the telemetry of apparatus.The information produced to patient, healthcare givers, insurance company, carry out clinical trial medical institutions and the tissue that family health care is monitored is served many purposes.

Data input and output can be undertaken by wired and/or wireless mode.Term " wired " in context refers to any such method, in the process, be provided with and control module is operably connected to external device (ED) (such as, palm PC, computer, mobile phone, network connection etc.) physical contact part, data are sent to control module by described physical contact part, or obtain data from control module.Term " wireless " refers to any such method, in the process, data is sent to control module or obtains data from control module, and without the need to using physical attachment.

When wired data transfer, the cable USB connector between control module and external device (ED) is an example that can provide.And USB type connector ubiquity, the equal physics of any type of connector contacted on a device meets contact on another device.Alternately, memory card (e.g., memory stick, secure digital (Secure Digital), flash drive etc.) may be used for transmitting data by memory card mobile between control module and external device (ED).

When wireless data transmission, numerous standard as known in the art can be used.This wireless connections comprise various radio frequency as known in the art and optics (e.g., infrared ray) connects.For relatively short-range radio communication, known bluetooth, Home RF, the well-known communication protocol such as IEEE802.11b, IEEE802.11a and IEEE802.15.4 can be used.Data for longer distance are transmitted, and can use the mobile phone agreement of such as CDMA, TDMA, GSM and WAP and so on.

These methods need not use isolatedly, and on the contrary, these methods advantageously can combine use.Such as, control module can under short-range condition with local " base station " by wired or wireless institutional communication, then described base station can be used one of mobile phone agreement or be collected the communication with external apparatus at station place by other wiring of twisted pair telephone, cable television or user present position and such as NO or central data.This can extend the life-span of the battery in control module by the electric power reducing communicating requirement, and line power voltage supply can be passed through in base station.

Be known in the art multiple battery technology, comprise conventional alkaline cell, hydrogen oxygen cell, lithium battery etc.The preferred battery technology that can adopt has following three kinds: NI-G (NiCad) battery, nickel metal hydride (NiMH) battery and lithium ion (Li-ion) battery, most preferably lithium ion battery.The exemplary power consumption of battery power supply system is 45 MAHs under 4.8 laid shoot parts.In the structure that can be provided by 4 joint AAA type nickel metal hydride battery groups, system described herein easily can run the length of one's sleep of 8 hours.Alternately, 2 Li-ion batteries piles saving 300 MAHs that voltage is 7.4 volts can provide similar performance.Use provides the lithium ion battery of the single-unit 3.7 volts of at least 600 MAHs to run 8 hours continuously by most preferred system.

When rechargeable battery, battery can be provided with wired socket, to be connected to traditional charger, and the contact on charge with battery in its contact " station " mates, or be also provided with inductively part, described inductive coupled uses induction coil, and described induction coil will be positioned on the surface of vacuum module.

F. to the compensation of the change vacuum that motion causes

The internal volume causing apparatus due to motion changes, and therefore simple body kinematics can change the power being applied to user cervical region significantly.Such as, if consider that the apparatus of the interior compartment volumes with 8.6 cubic inches is attached to adult male, swallowing act may make the volume of described compartment increase about 1.7 cubic inches because of the displacement due to throat, increase 20% nearly.

Although therapeutic kit can have certain bending ability, described apparatus must have enough rigidity, to keep the interval between described apparatus and throat.Therefore, the volume increase caused by motion is perceived as the pressure being applied to user throat and increases suddenly.Perfect gas law can be used to come the air pressure modeling in described therapeutic kit, and described perfect gas law specifies that gas pressure is relevant with the volume occupied by air.According to formula PV=nRT, determined the state of this gas by the pressure of a certain amount of gas, volume and temperature, wherein, P is absolute pressure, and V is container volume, and n is the molal quantity of gas, and R is universal gas constant, and T is absolute temperature.

If suppose to need the partial vacuum being greater than about 7.6 cm of water to obtain useful curative effect, and suppose because throat is subjected to displacement, motion can make the volume closed by described therapeutic kit increase suddenly 20% or more, those skilled in the art will recognize that the increase of closed volume causes the partial vacuum in therapeutic kit to increase identical 20%.The unexpected increase that the consequent contact surface place at described apparatus is applied to the power of throat tissue may cause discomfort to wearer, and makes it wake up with a start from sleep.

When integrated portable apparatus designs, because the volume of vacuum source with the related fittings being connected to evacuable compartments is minimized, is especially a problem so the vacuum that this motion causes increases.Therefore, compared with total vacuum space volume, the percentage ratio of the change in volume that motion causes can be more remarkable.In other words, the volume of the interior compartment of described apparatus and relevant vacuum system is less, by swallow or the additional power that causes of coughing then larger.

Therefore, can provide buffer unit, the partial vacuum produced in the described apparatus caused by these motions with damping fluctuates.This can be modeled as the movable barrier film being attached to spring the most simply.Spring tension is configured to, when time in the allowed band that partial vacuum is in design, barrier film is remained on appropriate location.That is, if described apparatus is designed to produce about 18 centimetres of H ₂the partial vacuum of O, then, under this pressure condition, spring both can not compress and also can not expand.Can with scheduled volume prestrain buffer spring under treatment vacuum level condition, make under this vacuum level, the barrier film of described apparatus is held in a predetermined position.Such as, if beyond the vacuum level expected, when user is swallowed, spring will allow diaphragm movement, to compensate the unexpected increase of closed volume at least in part.If spring fitting is (relative to partial vacuum) inside barrier film, then spring will compress; If spring fitting is outside barrier film, then spring will be expanded.Once in motion terminates, and spring just recovers its original shape, thus makes barrier film turn back to its initial position.Result alleviates the pressure increase that user feels.

Although be described according to spring and barrier film, for those of skill in the art, other structure is also apparent.Such as, buffer unit can be set to the part on described apparatus surface, when inner vacuum exceedes aspiration level, this surface portion can curve inwardly, and subsequently when vacuum increases disappearance, this surface turns back to its initial position.

G. acoustic management and elimination

Because device described here mainly uses between sleep period, the ability therefore minimizing the interference caused due to noise and/or vibration provides clear superiority to user.This area can pumping technology in manyly produce a large amount of noise during use.And when opening and closing pump circulation time at night, the unexpected change of sound level is to sleep very disruptive.Therefore, in certain embodiments, device described here with by manage, shelter and/or eliminate use therapeutic kit during the sound that produces provide the device of the comfort level of improvement to be connected.

Term used herein " acoustic management " refers to the sound level reducing device and produce.The motor run up often makes a noise; The motor of low-speed running is tending towards quiet.As discussed above, the speed of dc motor is controlled by pulse width modulation (PWM) usually.When motor rotating 360 degrees, most of positive displacement pump can not apply constant torque load on motor.On the contrary, they have upstroke and down stroke.When fast turn-around, this change of torque causes rotary inertia to lose, and motor sounds noisy.

But in the dc motor of outside rectification, electronic equipment accurately can determine the position of pump/motor in 360 degree of rotations.In a preferred embodiment, controller for increase pump stroke rotating part during electronic pulse width, and reduce the pulse width of the remainder of pump stroke.By mapping the torque curve of the pump applying of motor and making this torque curve and pulse width curves overlapped, pump/motor can be made to run more lentamente, thus noise-decreasing and vibration.

In certain embodiments, therapeutic kit of the present invention and sound mask electronic equipment combined, to shelter at least in part by machinery and the noise that produces of electronic unit.Term used herein " is sheltered sound " and is referred to and adds the nature of different frequency to environment or artificial sound (is commonly called " white noise " or " powder noise ", although these addresses are not too accurate), to pass through to use auditory masking " covering " or " covering " less desirable sound.Sound mask alleviates or eliminates the perception to the sound be pre-existing in given area, and working environment can be made more comfortable, meanwhile, provides and well talks privacy, so workman can work more fruitfully.Sound mask also can be applied to open air, to reduce more naturally surrounding.

Sound mask is generally used for architectural acoustics field and makes electronic music, to shelter distractive less desirable noise.Simply " white noise " machine can be very simple, comprises closed fan and (optional) speed switch.This fans drive air by the sulculus in machine case, thus produces the sound expected.More complicated machine can be electronics, and provides various " natural sound ".As shown in Figure 9, sound generator can be carried on apparatus from it, or also can to provide as a separate unit.

Similarly, in certain embodiments, therapeutic kit of the present invention combines with the electronic equipment of noise elimination, to shelter the noise produced by machinery and electronic unit at least in part.Term used herein " noise elimination " refers to and provides phase cancellation pressure wave.Sound can be counted as pressure wave, and it is made up of close phase and lean phase.Noise elimination speaker sends has same-amplitude but the sound wave of polarity contrary (anti-phase) with original sound.In the interventional procedures be called, these ripples are combined to form new ripple, and effectively cancel out each other, and this effect is called phase cancellation effect.Environmentally with method used, consequent sound wave can be faint to the unheard degree of people's ear.

Compared with random sound, the sound of circulation, even the circulation sound of complexity, more easily eliminates because waveform repeats.Thus, sound is eliminated and is particularly useful for the present invention.In a preferred embodiment, mike is placed near ear, and the electronic circuit producing " noise resistance " sound wave is carried by the speaker of the earphone or earplug form that are placed on ear place, wherein, the polarity of being somebody's turn to do " noise resistance " sound wave is contrary with the polarity of the sound wave arriving mike.This causes brokenly destructive interference, and this destructive interference eliminates the noise in the envelope volume of ear.Damping circuit or sound mask circuit can be loaded in apparatus from it, or can to provide as independent unit.Sound from circuit can be provided by little speaker or earplug.

H. other element

Full content (comprising all charts, accompanying drawing and claim) is incorporated to WO08/076421 and WO09/143259 of the present invention all by reference at this and describes the negative pressure treatment apparatus blocked for alleviating respiratory tract.These publications describe Various Components, and these elements can be provided with equipment of the present invention with different combinations.These elements comprise:

The first combination provides a kind of therapeutic kit, described therapeutic kit comprises: outer surface, described outer surface be configured to match with the perimeter covering upper respiratory tract of throat and thus encapsulate described region, thus, upon a match, the compartment that described therapeutic kit provides space to fill between surface and described throat within it, described compartment has 0.5 to 12in ³closed volume; And air pump, described air pump is operably connected to described compartment, and is configured to keep the partial vacuum in described compartment to be in 7.6 centimetres of levels to 61 cm of water, meanwhile produces the sound level lower than 40dB SPL.

The second combination provides a kind of therapeutic kit, described therapeutic kit comprises outer surface, described outer surface be configured to match with the perimeter covering upper respiratory tract of throat and and then close described region, thus, upon a match, the compartment that described therapeutic kit provides space to fill between surface and described throat within it, the closed volume of described compartment is 0.5 to 12in ³; And air pump, described air pump is operably connected to described compartment, and is configured to retaining part vacuum in described compartment, and wherein, described air pump comprises positive displacement pump.

The third combination provides a kind of therapeutic kit, described therapeutic kit comprises: outer surface, described outer surface be configured to match with the perimeter of the covering upper respiratory tract of throat and and then close described region, thus, upon a match, the compartment that described therapeutic kit provides space to fill between surface and described throat within it, the closed volume of described compartment is 0.5 to 12in ³; Wherein said therapeutic kit comprises buffer unit, and described buffer unit is configured to damping and is moved by user the fluctuation of the partial vacuum in the described apparatus that causes; And air pump, described air pump is operatively coupled to the compartment that described space is filled, to provide partial vacuum in described compartment.

4th kind of combination provides a kind of therapeutic kit, described therapeutic kit comprises: outer surface, described outer surface be configured to match with the perimeter of the covering upper respiratory tract of throat and and then close described region, thus, upon a match, the compartment that described therapeutic kit provides space to fill between surface and described throat within it, the closed volume of described compartment is 0.5 to 12in ³, wherein, the described neighboring partial vacuum be configured in described closed volume is about 7.6 centimetres provides 60 millimetress of mercury or less pressure along the contact surface with user contact skin to the condition of about 61 centimeter water columns; And air pump, described air pump is operably connected to described compartment, and is configured to retaining part vacuum in described compartment.

5th kind of combination provides a kind of therapeutic kit, described therapeutic kit comprises: outer surface, described outer surface be configured to match with the perimeter of the throat covering upper respiratory tract and and then close this perimeter, thus upon a match, the compartment that described therapeutic kit provides space to fill between surface and described throat within it, the closed volume of described compartment is 0.5 to 12in ³, and there is vacuum control module, described vacuum control module comprises microcontroller and electromotor control circuit, and described microcontroller is connected to vacuum or pressure transducer, described electromotor control circuit control pump ON/OFF circulation and/or speed.

6th kind of combination provides a kind of therapeutic kit, described therapeutic kit is a kind of single integral member with biocompatibility, described element is providing sealing member with skin contact place, the escape of air of described sealing member is lower to the leak rate of described enclosed compartment, and preferably leak rate is between 0.005 and 0.5in ³between/min, most preferably between 0.01 and 0.1in ³between/min; Membrane pump, described membrane pump uses rotating brushless dc motor or linear DC motor to drive, and its single-stroke discharge capacity is in 0.001 and 0.01in ³between, preferably between 0.003 and 0.005in ³between; And vacuum control module, the ON/OFF that described vacuum control module comprises microcontroller and the control pump be connected with vacuum or pressure transducer circulates and/or the electromotor control circuit of speed.

Although enough to have described in detail and exemplified with the present invention, so that those of skill in the art can manufacture and use the present invention, but under the prerequisite not deviating from the spirit and scope of the present invention, various replacement scheme of the present invention, modification and deformation program should be apparent.The example provided herein is the representative of preferred embodiment, and not as the restriction to protection scope of the present invention.Those skilled in the art can expect changing it and other purposes.These amendments are all encompassed in spirit of the present invention, and limited by the scope of claim.

Those of skill in the art be it is evident that, under the prerequisite not deviating from scope and spirit of the present invention, various substitutions and modifications can be made to invention disclosed herein.

The all patents mentioned in this description and publication all indicate the level of the those of ordinary skill in the field that the present invention relates to.All these patents and publication are incorporated to the present invention all by reference, just as each independent publication especially and be incorporated to the present invention individually by reference.

When lack herein with no specific disclosure of any element or multiple element, restriction or multiple restriction, also can implement the invention suitably described illustratively herein.Therefore, such as, in various situation of the present invention, term " comprises ", " substantially by ... form ", " by ... form " in any one all can replace with two other term.The term adopted and phrase are used as descriptive term and unrestricted, be not intended to get rid of in the process using these terms and phrase and illustrate and the equivalent of the feature described or its part, but it is to be appreciated that various amendment all can be in the scope of claim of the present invention.Therefore, should be understood that, although specifically disclose the present invention by preferred embodiment and optional feature at present, but those skilled in the art can adopt amendment and the variant of concept disclosed herein, and these amendments and variant will be considered as being in of the present invention by enclosing in claim limited range.

Set forth other embodiment enclosing in claim.

Claims

1. the equipment on the chin being configured to be located in patient and cervical region, described equipment is roughly being positioned at the external position at the soft tissue place relevant with the front triangle of described cervical region of described patient, the compartment that restriceted envelope is filled between the inner surface and the skin of user of described equipment, the neck surface that described equipment is suitable for being applied to described patient when the negative pressure for the treatment of level is applied in described compartment by power vacuum produced keeps or increases the opening of epithelium healing, wherein, described equipment is enough rigidity, to bear the negative pressure of the treatment level in described space, described equipment comprises:

Neighboring, described neighboring is configured to the skin contacting user, to close described compartment; With

Supporting member, described supporting member is positioned in the subregion of described neighboring of the chin closing on described patient, and described equipment is aligned on the chin of described patient by described supporting member.

2. equipment according to claim 1, wherein, a part for whole described neighboring or described neighboring comprises the closure of fluid filled.

3. equipment according to claim 2, wherein, the closure of described fluid filled comprises fluid, gel or foamed materials.

4. equipment according to claim 1, wherein, described supporting member is configured to loading force to be applied on the skin that contacts with described supporting member, produces described loading force when providing the negative pressure of described treatment level in described space.

5. equipment according to claim 1, described equipment also comprises flange, and described flange is attached to the subregion of described device end, when described equipment is located on described patient, the region between thyroid cartilage and jugular notch of described Hp contacts patient cervical region

Wherein, described flange its unloaded state flange at least partially on comprise non-linear horizontal section, and

Wherein, described non-linear horizontal section is configured to when described equipment is located on described patient and the negative pressure of described treatment level is applied in described compartment, improves the distribution of the load be applied on patient's cervical region relative to linear transverse section.

6. equipment according to claim 5, wherein, the region closing on cricoid cartilage of patient's cervical region described in described Hp contacts.

7. equipment according to claim 5, wherein, described flange comprises cohesive material, the whole described skin contact surface that described cohesive material is described flange or a part for described skin contact surface intrinsic, or described cohesive material is positioned in the whole described skin contact surface of described flange or a part for described skin contact surface.

8. equipment according to claim 5, wherein, described flange going up at least partially at its edge's rounding at described flange.

9. equipment according to claim 1, described equipment also comprises air pump, and described air pump can be operatively coupled to described equipment, to produce negative pressure in described compartment.

10. equipment according to claim 9, wherein, described air pump comprises piezoelectric, and described piezoelectric is configured to provide vibration pumping motion.

11. equipment according to claim 10, wherein, described vibration pumping motion is to be greater than the frequencies operations of 500Hz.